Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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EC number: 284-634-5 | CAS number: 84961-45-5 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Ceratonia siliqua. Leguminosae.
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 2017
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442D (In Vitro Skin Sensitisation: ARE-Nrf2 Luciferase Test Method)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- activation of keratinocytes
- Justification for non-LLNA method:
- Approved OECD method
Test material
- Test material form:
- liquid
- Details on test material:
- - Physical appearance: Dark brown to black liquid
- Storage of test material: At room temperature
Constituent 1
In vitro test system
- Details on the study design:
- According to protocol
Results and discussion
- Positive control results:
- Cinnamic aldehyde is included as positive control. It is tested in each test plate at five concentrations from 4 – 64 µM.
In vitro / in chemico
Resultsopen allclose all
- Key result
- Run / experiment:
- other: Reb 1
- Parameter:
- other: Study guideline
- Value:
- 1.21
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Run / experiment:
- other: Rep 1
- Parameter:
- other: Study guidelines
- Remarks:
- up to 200 ug/ml
- Value:
- 0.85
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Run / experiment:
- other: Rep 3
- Parameter:
- other: Study guidelines up to 200 ug/ml
- Value:
- 1.15
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- In all three repetitions, no induction of the luciferase above the threshold of 1.5 was noted. According to the prediction model of the KeratinoSens™ assay, the test substance is rated as a non-sensitizer. This conclusion is also clearly supported by the analysis of the dose-response curve in Figure 4 with overall no induction of the luciferase reporter gene to be observed.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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